Neoantigen vaccines for treating esophageal cancer
Neoantigen Vaccines in Combination with Immune Checkpoint Inhibitors for Maintenance Therapy Following Definitive Treatment of Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma: an Open-Label, Randomized, Phase II Study
This study is testing a new vaccine for people with advanced esophageal cancer to see if it can help them live longer and feel better after their treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sichuan University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Chengdu, Please Select) |
| Trial ID | NCT06675201 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a neoantigen-loaded dendritic cell vaccine as a consolidation therapy for patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC) following radical chemoradiotherapy. The study aims to determine if combining this vaccine with immune checkpoint inhibitors can improve overall survival and quality of life. Participants will undergo diagnostic endoscopy and provide fresh tumor tissue samples for neoantigen identification. The trial will assess various endpoints, including overall survival rates, progression-free survival, and quality of life metrics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with locally advanced unresectable ESCC who have undergone radical treatment and can provide fresh tumor tissue samples.
Not a fit: Patients with a history of gastrointestinal complications or those with poor nutritional status may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for patients with advanced esophageal cancer.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: A. Age 18-80 years B. Locally advanced unresectable ESCC patients after radical treatment (radical chemoradiotherapy or chemoradiation); including: * Cervical esophageal segment, T4, supraclavicular lymph node metastasis, or inability/refusal to undergo surgery due to personal reasons (refer to hospital below); ② Failure of neoadjuvant or conversion therapy; ③ Postoperative local recurrence, unresectable (target lesion present). C. No evidence of tumor recurrence or metastasis 2-3 weeks after radical treatment D. Ability to provide fresh tumor tissue samples (baseline) E. Normal major organ function F. Performance status (PS) score ≤ 1 G. Patients of childbearing potential must use contraception H. Voluntary participation with signed informed consent Exclusion Criteria: A. History of fistula caused by primary tumor invasion B. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation C. Poor nutritional status D. Immune-related adverse events during prior radical treatment, such as Grade ≥3 pneumonitis, myocarditis, etc. E. Signs and symptoms of interstitial diseases F. Presence of any severe and/or uncontrolled medical conditions G. Presence of concurrent malignancies H. Presence of other autoimmune diseases, or prolonged use of immunosuppressants or steroids I. Difficulty in patient communication or inability to comply with long-term follow-up J. Other conditions deemed unsuitable by the investigator
Where this trial is running
Chengdu, Please Select
- West China Hospital of Sichuan University — Chengdu, Please Select, China (Recruiting)
Study contacts
- Principal investigator: zhenyu ding, MD — West China Hospital of Sichuan University, ChengDu, China
- Study coordinator: zhenyu ding, MD
- Email: dingzhenyu@scu.edu.cn
- Phone: +86 028-854-22562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.